510(k) · Cleared
ClearedOmron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 28, 2005 as substantially equivalent to K032305 (Omron Healthcare, Inc., 2004) and 2 other predicates after a 269-day review. Its family tree reaches back 3 generations to 1987. 6 later devices descend from it.
- Decided
- Oct 28, 2005
- Review
- 269 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K872291 (1987). 12 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 2 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 1 generation backK013434 VP-2000/1000Colin Corp. · 2002
- This deviceK050233 Omron Non-Invasive Blood Pressure Monitor with Augmentation Index…Omron Healthcare, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK101002 A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK131916 Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK131788 Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP…Healthstats International Pte., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK121266 CardioscopePulsecor Limited · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007 · cites it directly4descendants
- K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010 · 2 generations on2descendants
- K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd. · 2014 · 2 generations on0descendants
- K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd. · 2014 · 3 generations on0descendants
- K121266CardioscopePulsecor Limited · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −2 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −1 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| 0 (this device) | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model… | Omron Healthcare, Inc. | 2005 | — |
| +1 | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | Healthstats International Pte., Ltd. | 2007 | — |
| +2 | K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | Healthstats International Pte., Ltd. | 2010 | — |
| +2 | K131916 | Bprosoft Casp PC Software | Healthstats International Pte., Ltd. | 2014 | — |
| +3 | K131788 | Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management… | Healthstats International Pte., Ltd. | 2014 | — |
| +3 | K121266 | Cardioscope | Pulsecor Limited | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032305 | Omron Intellisense Digital Blood Pressure Monitor, Model Hem-907XLSummary page 1…ulation Name: Non-invasive blood pressure monitor Regulation Class: II Product Code: DXN C. Modified Device HEM-907XL cleared under K032305 D. Predicate Devices VP- 1000/2000 cleared under K013434 SphygmoCor Px cleared under K012487 E. Device Descriptio… | 2004 |
| * | K013434 | VP-2000/1000Summary page 1…lation Class: II Product Code: DXN C. Modified Device HEM-907XL cleared under K032305 D. Predicate Devices VP- 1000/2000 cleared under K013434 SphygmoCor Px cleared under K012487 E. Device Description The HEM-9000AI is an oscillometric NIBP measurement and ap… | 2002 |
| * | K012487 | Sphygmocor PX Model Scor-PXSummary page 1…DXN C. Modified Device HEM-907XL cleared under K032305 D. Predicate Devices VP- 1000/2000 cleared under K013434 SphygmoCor Px cleared under K012487 E. Device Description The HEM-9000AI is an oscillometric NIBP measurement and applanation tonometry augmentation ind… | 2002 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K072593 (Healthstats International Pte., Ltd., 2007) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K032305.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The HEM-9000AI is intended to measure systolic and diastolic blood pressure, and
pulse rate in adults with an arm circumference of 17-50 cm (7-20 inches) and to
measure/calculate radial augmentation index (Al). The HEM-9000AI is intended for use
in physician's offices, hospitals, clinics and other medical facilities where non-invasive
blood pressure and radial augmentation index measurements/calculations are
performed on patients and invasive measurement is contraindicated.
The augmentation index (Al) function of the HEM-9000A1 has not been evaluated on
patients who have inter-ventricular conduction delays (IVCD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050233 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050233: Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050233
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026